Device to detect and treat Apneas and Hypopnea

ABSTRACT

A method and apparatus for the treatment of Sleep Apnea events and Hypopnea episodes wherein one embodiment comprises a wearable, belt like apparatus containing a microphone and a plethysmograph. The microphone and plethysmograph generate signals that are representative of physiological aspects of respiration, and the signals are transferred to an imbedded computer. The embedded computer extracts the sound of breathing and the sound of the heart beat by Digital Signal Processing techniques. The embedded computer has elements for determining when respiration parameters falls out of defined boundaries for said respiration parameters. This exemplary method provides real-time detection of the onset of a Sleep Apnea event or Hypopnea episode and supplies stimulation signals upon the determination of a Sleep Apnea event or Hypopnea episode to initiate an inhalation. In one embodiment, the stimulus is applied to the patient by a cutaneous rumble effects actuator and/or audio effects broadcasting.

TECHNICAL FIELD

The present invention relates to an apparatus to detect and endoccurrences of Sleep Apnea event and Hypopnea episode, in a manner thatwill decrease or eliminate hypoxia, hypercapnia and the disturbance ofpulmonary hemodynamics.

BACKGROUND

Sleep Apnea and Hypopnea are breathing disorders that occurs duringperiods of sleep. It is an intermittent cessation or reduction ofventilation during sleep that results in a decrease in blood oxygenlevels (hypoxia), increase in CO2 (hypercapnia), and vasoconstriction.The long term effects of these physiological changes are associated withthe development of cardiac arrhythmias, congestive heart failure,cardiac ischemia, hypertension, heart disease, brain damage, anddiabetes.

The causes of the various forms of Sleep Apnea and Hypopnea are notfully understood. There are three general types of Sleep Apnea:Obstructive, Central and Mixed. Obstructive Sleep Apnea (the most commontype) is a blockage or occlusion of the oropharyngeal (upper) airway dueto a loss of patency of its muscles. With Obstructive Sleep Apnea (OSA),respiratory functions continue as paradoxical movement of the thorax orabdomen. This paradoxical movement acts as a one way piston: air leavesthe lungs but little or none can enter. The cause or causes ofObstructive Sleep Apneas is still a matter of much debate and research.The average Apnea event lasts 20 seconds however events of 2 to 3minutes are not unknown. During the event, a number of physiologicalevents occur. These include a vagal bradycardia, an increase in bloodpressure, an increase in norepinephrine, and paradoxical respiratoryefforts with increased respirator efforts. As an apnea eventprogresses,there is an increasing effort to breathe, increasing carbon dioxide(Hypercapnia), decreasing oxygen, and increasing level ofproprioception. The longer the Apnea event, the more extreme thesechanges are. At the end of an Apnea event tone (patency) returns to theupper airway muscles so that the upper airway suddenly re-opens. Thiscan be associated with a sudden gasp or choking as air rapidly entersthe lungs and surges in Heart Rate and Blood Pressure.

Information parsed from various research papers: It has been believedthat an arousal from a deeper stage of sleep to a lighter stage of sleepwas required to terminate an Apnea episode; however studies have castdoubt on that assertion: “In summary, in the vast majority of patients,if not in all patients, arousal is required neither to initiate UA(Upper Airway) opening nor to obtain adequate flow. UA opening wouldoccur at approximately the same time regardless of when or whetherarousal occurs and the flow response in most patients would still betimely and adequate. Arousals are incidental events that occur when thethresholds for arousal and arousal-independent opening are close to eachother, as they appear to be in patients with OSA. By promoting anunnecessarily high flow response at UA opening, arousals help perpetuatecycling and likely exacerbate OSA.” (YOUNES, Magdy. Role of Arousals inthe Pathogenesis of Obstructive Sleep Apnea. American Journal ofRespiratory and Critical Care Medicine: Mar. 1, 2004. Role of Arousalsin the Pathogenesis of Obstructive Sleep Apnea. Which is herebyincorporated by reference. Although cortical activation is the goldstandard for definition of arousal, several studies show there aredifferent levels of central nervous system activation. At the lowerrange of arousal responses are those inducing reflex motor responses,autonomic activation, and appearance of slow wave EEG activity, i.e.,delta bursts (D-bursts) and K-complex bursts (Kbursts), all defined as“subcortical arousals.” At the upper range are arousal responsesimplying a cortical activation represented by MA6 and phases oftransitory activation (PAT).

These findings might corroborate the hypothesis of the existence of 2separate neural systems integrated in the arousal network and undergoingdifferent modulatory influences.”

Further studies indicate that overall, increasing ventilatory effort maybe the most important stimulus to arousal from sleep, and the stimulusto arousal from hypoxia and hypercapnia may be mediated principallythrough stimulating an increased ventilatory efforts.

These considerations raise the question of possible manipulation of thearousal response to maximize the beneficial effects related tofacilitating resumption of airflow, but minimize the adverseconsequences related to sleep fragmentation and post-apneahyperventilation. These latter effects appear to relate more to corticalthan brainstem arousal.

Furthermore some studies concluded that: “The current findings suggestthat strategies of induced arousal, at an intensity level stimulatingrespiration while avoiding recruitment of the ascending arousal systemand its potential effects of sleep disruption, could have potentialapplication as a therapeutic modality. Apnea was detected by trachealbreath sounds which were picked up by microphone . . . stimulationdecreased the frequency of apnea episodes and the longest apneaduration. This resulted in an increase in arterial oxygen saturation.Moreover stimulation decreased sleep stages I and II, and increasedstages III and IV. These findings suggest that stimulation using theapnea demand-type stimulator may be an effective treatment for OSA.”

Other research has determined that: the Psa (Blood Pressure) and HR(Heart Rate) increased more and the SV (Stroke Volume) decreased more inthe apnea that was terminated by an EEG (cortical) arousal compared withthe apnea without an EEG (subcortical) arousal.

Furthermore externally applied stimulus is reported to cause a “trendamong our subjects to shortening of the apnea immediately after thestimulated apnea; that is, the effect of the tone appeared to extend tothe next apnea. We would hypothesize that the acoustic stimuli did altersleep state and thus arousal threshold such that the immediatelysucceeding apnea might have been more susceptible to concurrentrespiratory afferent stimuli”. This took place in spite of the trend forObstructive Sleep Apneas to increase in both frequency and durationduring a nights sleep.

The kind of stimuli provokes different responses in human subjects:“Previous studies using single-modality paradigm have shown that sensorygating systems, which select relevant sensory information, remainfunctional during sleep In humans, relevant stimuli (e.g. sound >65 dB,one's own name, experimental noxious stimulation) induce arousalresponse more frequently and results in more intense response comparedwith irrelevant stimuli. Simultaneous multi-modality sensory inputs frombody surface and from other organs (e.g. ear) not only increase theamount of sensory inputs but also can maximize the relevance ofstimuli”. HALA'′ sz et al., 2004; Kisley et al., 2001; Velluti, 1997,which is hereby incorporated by reference.

Central Sleep Apnea results from the brain failing to signal the musclesto breathe. The neural drive to the respiratory muscles discontinues fora brief period of time. These transients may continue throughout thenight for periods from ten seconds to as long as 2 to 3 minutes. Thephysiological effects are similar to those of Obstructive Sleep Apnea.

Mixed Sleep Apnea is a combination of Obstructive Sleep Apnea andCentral Sleep Apnea. There are several known treatments for Sleep Apnea.They consist of physical, electrical, and mechanical methods, surgery,and attempts at pharmacological treatment. The treatment regimen istailored to the individual, and is based on the medical profile of thepatient being treated.

The most common effective treatment for patients with sleep apnea isnasal continuous positive airway pressure (CPAP). In this form oftreatment, the patient wears a mask over the nose while sleeping. Themask is connected to a compressor that creates a positive pressure inthe nasal passages. The continuous positive airway pressure systemprevents the airway from closing or becoming obstructed during sleep.The air pressure from the continuous positive airway system is constant,and can be adjusted to best suit the individual's apnea condition. Theair pressure in the continuous positive airway pressure system must beadjusted so that it maintains an open airway in the patient during allperiods of sleep, but does not provide excessive pressure such that thedevice is bothersome to the patient. U.S. Pat. No. 4,655,213 disclosessleep apnea treatments based on the principles of continuous positiveairway pressure. There have also been recent attempts at varying theapplied pressure to increase the effectiveness of continuous positiveairway pressure treatment. U.S. Pat. Nos. 4,773,411 and 6,539,940disclose such techniques. The disclosures of these United States patentsare incorporated herein by reference.

Another treatment for sleep apnea in certain patients involves the useof a Dental Appliance to reposition oral structures such as the tongueand the lower jaw. This form of treatment is typically performed by adentist or dental specialist such as an orthodontist. Surgery has alsobeen performed to treat sleep apnea. In some surgical treatments, thesize of the airway is increased. These surgical procedures containelevated levels of risk in comparison to other treatment methods, andoften times are not entirely effective. The form of surgery to beundertaken is specific to the patient and the patient's medical profile.The removal of obstructive tissue in the airway such as adenoids,tonsils or nasal polyps is a common form of surgical treatment for sleepapnea. The surgical correction of structural deformities is also acommon form of surgical treatment for sleep apnea.

Another form of surgical treatment for sleep apnea isuvalopalatopharyngoplasty. This procedure removes excess tissue from theback of the throat, such as tonsils, uvula, and part of the soft palate.Somnoplasty is also being investigated as a possible treatment for sleepapnea. Somnoplasty uses radio waves to reduce the size of some airwaystructures such as the uvula and the back of the tongue.

Other forms of surgical intervention for sleep apnea includemaxillo-facial reconstruction. Another form of surgical treatment forpatients with severe and life threatening sleep apnea is Tracheostomy.This procedure involves making a small hole in the windpipe thataccommodates a tube. The tube is opened only during sleep, and allows apatient to take air directly into the lungs, effectively bypassing anyupper airway obstructions. Tracheostomy is an extreme procedure that isvery rarely used except for cases of imminent life threatening sleepapnea.

Attempts at pharmacological treatment for sleep apnea have includedrespiratory stimulants such as theophylline, acetazolamide andmedroxy-progesterone, and adenosine. Drugs that stimulate brain orcentral nervous system activity, such as naloxone and doxapram, havealso been used in an attempt to treat sleep apnea. Other drugs that acton the neurotransmitters involved with respiration have also been usedin an attempt to treat sleep apnea. These drugs include serotonin,dopamine, tryptophan, fluoxetine, and others.

More recently, systems have been developed for the purpose of clearingupper airway passages during sleep using the electrical stimulation ofnerves or muscles. In some cases, these systems require surgicalimplantation of sensors and associated electronics that detect whenbreathing has ceased and then stimulate the breathing process. Somehybrid systems have been developed that require surgical insertion ofone or more sensors plus external equipment for monitoring the breathingprocess or moving the obstruction when breathing ceases.

An apparatus has been patented a means for detecting the onset of asleep related disorder using pulse rate and blood oxygen contentinformation as measured by the device; U.S. Pat. No. 7,387,608 disclosessleep apnea treatments based on those principles. The disclosures ofthese United States patents are incorporated herein by reference.

An apparatus has been patented a means for detecting the onset of asleep related disorder using a multiplicity of microphones. Theapparatus has the microphones emplaced within a collar worn around theneck of the patient. The apparatus detects breathing sounds, and in anembodiment when it detects breathing that is “substantially differentfrom the recorded at least one signal pattern that is associated with anormal breathing pattern of the person; and creating a stimulus to theperson's neck muscles to cause the -person to move the person's neckmuscles to move the person's head backwards to restore normal breathingbefore cessation of breathing occurs”, as disclosed in U.S. Pat. No.6,935,335. The disclosures of these United States patents areincorporated herein by reference.

SUMMARY OF THE INVENTION

The present invention is directed to a apparatus and method fordetecting and treating Sleep Apnea and Hypopnea by terminating a SleepApnea event or Hypopnea episode within seconds of detection.

The invention develops through a Method a Referential set of Parametersspecific to the respiration patterns of the specific patient (ratherthan defining and applying Generic Trigger point Parameter as is thecase with other inventions). The multiplicity of Signal Parameterscombined with a Fuzzy Control System is more adaptable to the changes ofRespiration that occurs during the course of the night. Changes ofRespiration which might be interpreted by other inventions (such asthose who use averaging or weighted moving averaging of invention anddetermined to be a reversion to a Respiration pattern that is normal forthis specific patient. Normal for the patient is established by theProcessing of the Referential set of Parameters within the Fuzzy ControlSystem. The inventions method of using both the root-mean-squaredeviation of a parameter and the parameters' mean, as opposed to simplyaveraging or weighted moving averaging of the parameter, to establish areference point for determination of a parameters' out of boundcondition, is a superior method for detecting Apnea events or Hypoxiaepisodes.

In accordance with the present invention, there is provided a wearable,belt like, apparatus for the treatment of Sleep Apnea events andHypopnea episodes containing a Microphone and a Plethysmograph. TheMicrophone and Plethysmograph generate signals that are representativeof physiological aspects of respiration. The signals are transferred toan imbedded computer. The embedded computer extracts the sound ofbreathing and the sound of the heart beat by the means of Digital SignalProcessing techniques. The embedded computer has means for determiningwhen respiration parameters falls out of defined boundaries for therespiration parameters. This method is for the real-time detection ofthe onset of a Sleep Apnea event or Hypopnea episode. The embeddedcomputer supplies stimulation signals upon the determination of a SleepApnea event or Hypopnea episode to initiate an inhalation. Thestimulation is provided in a manner so as to avoid the initiation of acortical (EEG} arousal and vagal withdrawal of the parasympathetic toneto the heart. The stimulus is applied to the patient by a cutaneousrumble effects actuator and audio effects broadcasting. The actuator isembedded within the invention. It is a primary object of the presentinvention to provide a system and method for detecting and terminatingan Sleep Apnea event and Hypopnea episode, within seconds of thedetection, in a manner that will decrease or eliminate hypoxia,hypercapnia and the disturbance of pulmonary hemodynamics respirations)as an Apnea Event or Hypopnea episode could be Processed by the presentinvention.

Technical Problem

Positive Airway Pressure (PAP) systems remain the most effectivetreatment for sleep apnea. Many patients, however, cannot tolerate thePositive Airway Pressure systems and associated apparatus. Commoncomplaints include discomfort with the applied pressure, discomfort withthe mask and equipment, nasal irritation, nasal stuffiness andcongestion, airway dryness, mask air leaks and noise, entanglement,claustrophobia, noise of the PAP machine, headaches, abdominal bloating,sore and irritated eyes, and an overall discomfort with the machinery.The noise and general obtrusiveness of the PAP apparatus are oftendisruptive to another person sleeping with the user. A significantminority of the people for whom PAP is prescribed (estimated to be 30%to 50%) refuse to use it. A study determined that of the patients whouse PAP treatment, it is estimated that 34% use it intermittently (4nights per week) and/or remove it for part of the night (for this groupmedian nightly usage is 3.1 hours). Beyond the initial cost of the PAP(>U$500.00) there is a continuing cost of replacement masks. It isrecommended that masks be replaced every six months (=>U$100.00/mask).

A study determined that Dental Appliances was successful in treating OSAin an average of 52% of treated patients, with success defined as nomore than 10 apneas or hypopneas per hour of sleep. Treatment adherenceis variable with patients reporting using the appliance a media of 77%of nights at 1 year. A Dental Appliance typically has a cost in excessof U$1000.00

Surgery has inherent risks: its' cost is high, its' success rates varyand over a period of time its' effectiveness fades. Pharmacologicaltreatments for sleep apnea have not achieved any consistent levels ofeffectiveness, and often contain side effects. Systems that clear theupper airway passages during sleep using the electrical stimulation ofnerves or muscles. These systems may produce positive results but theyalso have associated risks due to surgery, may need replacement at latertimes (requiring additional surgery), and may have higher costs andlower reliability than the more traditional treatments. In addition, thehybrid systems also have the accompanying physical restrictions andaccompanying disadvantages associated with connections to the externalequipment.

An apparatus whose means for detecting the onset of a sleep relateddisorder relies on blood oxygen content information cannot determine theonset of a sleep order in real time. Oxygen saturation leveldiminishment always lags the cessation of breathing because it takestime for the as oxygen in the bloodstream to used up by bodilyprocesses. Hypoxia and hypercapnia will occur.

An apparatus whose sole means for detecting the onset of a sleep relateddisorder relies on detecting the sounds of breathing can be confused byextraneous noises, coughing, wheezing and other internally generatedbiologic noises. In addition in order for both the microphones andstimulus devices to work most effectively they must be in close contactwith the neck and this constriction may prove to be unacceptablyuncomfortable to the patient. Many of these devices provide a singletype of auditory stimulus (a fixed tone of varying intensity) and/ormechanical stimulus (a vibrator). For example, U.S. Pat. Nos. 7,387,608discloses such techniques. It is Claimed that: “The method of arousingthe patient from sleep at the onset of a sleep apnea event will decreaseor eliminate the occurrence of sleep apnea, arrhythmia, and partialepilepsy over time”

These methods of stimulus may prove to be initially effective inreducing the numbers of Apnea events through a process of Conditioning.However, with Conditioning there co-exists Habituation. These are twointeracting psychological phenomena with a number of similarities. InConditioning, an animal is exposed to some events, and as a consequence,it learns to associate a certain behavior with a specific situation. InHabituation too, an event occurs repeatedly, but in this case, thereaction of the animal wanes with repeated exposure. The dynamics ofHabituation is very similar to the extinction of a response that haspreviously been learned during Conditioning. In both cases, the responsebecomes less probable or weaker with each occurrence with the event.There is one large difference between the two situations, however. Inextinction, a learned response is weakened, but in Habituation thereaction that dies away is typically an innate orienting reaction.Conditioning may indeed lead to extinguishment of Sleep Apneas events orthe opposite may occur; Habituation might lead to the patient ignoringthe stimulus. If Habituation occurs then Sleep Apnea events wouldcontinue until they spontaneously terminate.

Solution to Problem(s)

Therefore, there is a need in the art for an improved system and methodfor treating Sleep Apnea events and Hypopnea episodes. In particular,there is a need in the art for a system and method that does not createother types of sleep disturbing effects, does not require surgicalimplementation, does not involve the use of a complicated apparatus,does not include the use of pharmaceuticals, does not require theintervention of health professionals, and does not have the high costsassociated with some of the types of treatments currently in use.Therefore, there is a need for a system and method for treating SleepApnea event and Hypopnea episode by terminating a Sleep Apnea event andHypopnea episode in real time that minimizes the disturbance topulmonary hemodynamics. Therefore, there is a need for a system andmethod for treating Sleep Apnea event and Hypopnea episode that is easyto use by the patient, comfortable, and less expensive than othermethods of treatment.

Advantageous Effects of Invention

An Advantageous Effect of Invention is the superior method of detectionof Sleep Apnea events and Hypopnea episodes: Using the standarddeviation of a parameter in conjunction with the parameters' mean and arules based processing (Fuzzy Logic) as opposed to using only aparameters' mean as a reference point for determination of a parameters'out of bound condition (excursion) leads to the diminishment of theoccurrence of the invention detecting a false Apnea event or Hypoxiaepisode.

In the situation where the parameters' mean is the only reference, asingle excursion beyond an established limit leads declaration of anApnea event or Hypoxia episode. Conversely, with this method of theinvention, when an excursion is determined, a further determination isperformed to establish if the excursion is smaller than every member ofthe set of parameters that were gathered during the Self-calibrationsprocesses. For while an excursion might be smaller than the mean of theparameter that was calculated by the processes the Self-calibrations, itmight be greater than any single parameter that formed the set ofparameters that were determined to be “normal” for this specific patientand which formed the reference set of parameters. The use of rules basedprocessing (Fuzzy logic) allows the invention to evaluate thesignificance of excursions and make decisions as to whether as excursionmerits initiating Stimulus. The invention analyzes a multiplicity ofparameters derived from redundant apparatus to detect respirations. Theuse of rules based processing (Fuzzy logic) allows the invention toevaluate the significance of excursions of any single parameter or anycombination of parameters from the redundant apparatus and makedecisions as to whether as excursion merits initiating Stimulus.

Another Advantageous Effect of the Invention is its' ease of use. Manyof the patients who would use the invention are both obese and old(er).The invention is simple to don. The invention uses plain languagecommands to guide the patient in to properly position the invention.

Another Advantageous Effect of the Invention is it is not anencumbrance. The sleeping patient is not physically constrained. This isimportant in light of the fact that many of the patients have enlargedprostrates which, in many cases, necessitates frequent urination duringthe night.

Another Advantageous Effect of the Invention is that it is lessexpensive that most other solutions. From the perspective of overallcosts: It does not require the programming of baseline parameters.Baseline parameters that have to be entered into an apparatus wouldrequire that there be an evaluation of the results from the patients'polysomnography and using a method to establish baseline criteria. Theinvention self determines the baseline parameters. There are noreplacement components. Other devices require periodic replacement ofkey components, at a considerable expense. The invention is no moreexpensive that the average price of the most popular form of treatmentfor Obstructive Sleep Apnea (CPAP).

Another Advantageous Effect of the Invention is that it can be used inconjunction with the most popular form of treatment for ObstructiveSleep Apnea (CPAP) or as an alternate, independent form of treatment.There is a significant minority or patients who use the CPAPintermittently. Using the invention during those times that the patientis not using CPAP would continue the benefit to the patient that isrealized by maintaining normal blood oxygen and carbon dioxide levels.

Another Advantageous Effect of the Invention is it is self-adapting; itself-determines referential baselines for the specific patients' normalrespiration patterns. One of the definitions of Obstructive Sleep Apneais interruptions in airflow of at least 10 seconds. The invention may,depending on the normal respiration pattern of that patient, establish adifferent baseline as to what an interruption of airflow in secondswould be. By immediately applying a Stimulus that has been determined toinitiate an inhalation at the lowest level of stimulation, the effectson the physiology of the patient of the Apnea event or Hypoxia episodewill be minimized.

Another Advantageous Effect of the Invention is that there are devicesthat ramp up the stimulus (be it the frequency of a mechanical vibratorand/or audio and/or amplitude) until respiration is restored. This takestime, in which case the deleterious effects of declining blood oxygenand increasing blood carbon dioxide accrue, and if it overshoots (therebeing a delay between the time a stimulus is applied and the reaction ofthe patient to it) it could lead to a heightened waking than is requiredto terminate the Apnea event or Hypoxia episode.

Another Advantageous Effect of the Invention is that it isself-adapting; it self-determines referential baselines for the type ofStimulus that is required to terminate an Apnea event or Hypoxiaepisode. Research has shown that the amount of stimulus required toinitiate an inspiration changes in cycles during sleep. The inventioncontinuously evaluates the Stimulus required to terminate an Apnea eventor Hypoxia episode.

Another Advantageous Effect of the Invention is that it can supply avery wide range of Stimulus. It has a multiplicity of embedded Audiofiles and Haptic pattern files, each with a distinct irritation index.The invention will determine which files produce the Stimulus requiredto initiate an inhalation at the lowest level stimulation. Since thereare many file combinations that will produce the Stimulus required toinitiate an inhalation at the lowest level stimulation, the inventioncan avoid Habituation while maintaining the benefit of Conditioning.

BRIEF DESCRIPTION OF DRAWINGS

The invention will be described by reference to the following drawings,in which like numerals refer to like elements, and in which:

FIG. 1 is a top and Bottom External view of the present invention;

FIG. 2 is a Cross-section view;

FIG. 3 is a Block Diagram of the manner in which Microphone andPlethysmographic sensor data is converted into Signals;

FIG. 4 is a Block diagram of the Electronic and Electrical elements ofthe invention;

FIG. 5 is a Block Diagram of the Training and Monitoring Processes;

FIG. 6 is a Block Diagram of the Fuzzy Control System; and

FIG. 7 is a diagram of a Patient wearing the invention.

FIG. 8 is a Block Diagram of Portrait Development

DESCRIPTION OF EMBODIMENTS

Accordingly, embodiments of the present invention are provided that meetat least one or more of the following objects of the present invention.In one embodiment, a wireless auditory prompter (Bluetooth Earbud) ismounted in the patient's ear and is activated by the stimulation signalto emit an acoustic stimulus which is heard by the patient but isinaudible to others. This embodiment provides a sound to initiateinhalation without requiring other intervention. In another embodiment,a wired auditory prompter is mounted in the patient's ear and isactivated by the stimulation signal to emit an acoustic stimulus whichis heard by the patient but is inaudible to others. This embodimentprovides a sound to initiate inhalation without requiring otherintervention.

In another embodiment, a loud speaker is embedded within the inventionand is activated by the stimulation signal to broadcast an acousticstimulus which is heard by the patient. This embodiment provides a soundto initiate inhalation without requiring other intervention. In anotherembodiment, the computer detects the absence of a heartbeat andactivates an audible alarm by the loud-speaker embedded within thepresent invention.

In another embodiment, the computer has means to store the calculatedamplitude, periodicity, and duration of respiration for each respirationof the collection of known good respirations from the firstself-calibration in imbedded memory. In another embodiment, the computerhas means to store the calculated values and parameters in imbeddedmemory.

In another embodiment, the computer has means to store the time(s) inwhich a Sleep Apnea event and Hypopnea episode occurs in imbeddedmemory. In another embodiment, the computer has means to store thetime(s) in which a Sleep Apnea event and Hypopnea episodes areterminated in imbedded memory.

In another embodiment, the computer has means to export the calculatedvalues and parameters from imbedded memory to other devices.

In another embodiment, the computer has means to export the time(s) inwhich a Sleep Apnea event and Hypopnea episode occurs and from imbeddedmemory to other devices.

In another embodiment, the computer has means to export the time(s) inwhich a Sleep Apnea event and Hypopnea episode are terminated fromimbedded memory to other devices.

In another embodiment, the computer has means to import modifications ofthe computer programs from other devices.

In another embodiment, the computer has means to import modifications ofthe computer program that comprises the rules based processing (FuzzyLogic) from other devices.

In another embodiment, the plethysmographic sensor can be implementedusing a string potentiometer. In another embodiment, theplethysmographic sensor can be implemented using strain gauges.

In another embodiment, the plethysmographic sensor can be implementedusing accelerometers.

In another embodiment, the plethysmographic sensor can be implementedusing Hall Effect components.

In another embodiment, the plethysmographic sensor can be implementedusing LEDS and Photo detectors.

In another embodiment, the plethysmographic sensor can be implementedusing ultrasonic sensors.

In another embodiment, there might be a plurality of microphones.

In another embodiment, the mechanical tactile sensory stimulator may beimplemented using a Haptic Display.

In another embodiment, the mechanical tactile sensory stimulator maybeimplemented using a Haptic Display comprising shape memory springs.

In another embodiment, the mechanical tactile sensory stimulator maybeimplemented using a Haptic Display using multiple actuators.

In another embodiment, the mechanical tactile sensory stimulator maybeimplemented using a Haptic Display comprising rotating drums.

In another embodiment, the mechanical tactile sensory stimulator maybeimplemented using a Haptic Display comprising electroactive polymers.

In another embodiment, sensory stimulation may be applied optically bythe donning of a device that is worn over the eyes and in which LEDsshine light through the eyelids into the pupils.

The foregoing has outlined rather broadly the features and technicaladvantages of the present invention so that those skilled in the art maybetter understand the detailed description of the invention thatfollows. Additional features and advantages of the invention will bedescribed hereinafter that form the subject of the claims of theinvention. Those skilled in the art should appreciate that they mayreadily use the conception and the specific embodiment disclosed as abasis for modifying or designing other structures for carrying out thesame purposes of the present invention. Those skilled in the art shouldalso realize that such equivalent constructions do not depart from thespirit and scope of the invention in its broadest form.

Before undertaking the Detailed Description, it may be advantageous toset forth definitions of certain words and phrases used throughout thispatent document: the terms “include” and “comprise” and derivativesthereof mean inclusion without limitation; the term “or,” is inclusive,meaning and/or; the phrases “associated with” and “associatedtherewith,” as well as derivatives thereof, may mean to include, beincluded within, interconnect with, contain, be contained within,connect to or with, couple to or with, be communicable with, cooperatewith, interleave, juxtapose, be proximate to, be bound to or with, have,have a property of, or the like; and the term “controller” means anydevice, system or part thereof that controls at least one operation,such a device may be implemented in hardware, firmware, or software, orsome combination of at least two of the same. Definitions for certainwords and phrases are provided throughout this patent document. Those ofordinary skill in the art should understand that in many, if not most,instances, such definitions apply to prior, as well as future uses ofsuch defined words and phrases.

“Measurement” by the Computer in this application is defined as anAnalog-to-Digital Conversion. The derivative of Analog-to-DigitalConversion is a numeric value that is representative of the SignalsAmplitude at the time that the Measurement is made. Those skilled in theart will understand the method of using Analog-to-Digital conversion.

“Processing”, “Process”, “Monitoring”, and “Method” are usedinterchangeably in this document and are collectively defined as theapplication of software programs that are resident within the Computeras means or manner of procedure to accomplishing something. The meansand reasons for the Processing will be addressed in detail within thisdocument.

Other objects and features of the present invention will become apparentfrom the following detailed description considered in conjunction withthe accompanying drawings. It is to be understood, however, that thedrawings are designed solely for purposes of illustration and not as adefinition of the limits of the invention, for which reference should bemade to the appended claims. For a general understanding of the presentinvention, reference is made to the drawings. In the drawings, likereference numerals have been used throughout to designate identicalelements. In accordance with this present invention, there is providedan apparatus and method for the diagnosis and treatment of Sleep Apneaand Hypopnea. In one embodiment of the invention, the respirations ofthe patient are monitored during sleep by the apparatus, which acts as amonitoring system to detect and treat Sleep Apnea events and Hypopneaepisodes in the patient. The monitoring system is comprised of aintegrated plethysmographic, a integrated microphone, a integratedcomputer and software program, and methods for applying stimulus to thepatient such as a integrated loud speaker, wired and wireless audio, anda integrated rumble effects actuator. The invention is a wearable,belt-like device, the device is fitted around the Thorax or Abdomen of apatient.

At the onset of a Sleep Apnea event or Hypopnea episode the respiratoryinduced movement (expansion and contraction) of the Thorax and/orAbdomen are significantly reduced. In addition, the movement of air intothe lungs is significantly reduced. These decreases are indicators of anonset of a Sleep Apnea event or Hypopnea episode. During sleep, it isnormal for the patients' respiration parameters for amplitude,periodicity, and duration of respiration to vary. Discerning betweenthose normal variations in the parameters (for amplitude, periodicity,and duration of respiration during sleep) and abnormal variations inparameters (for amplitude, periodicity, and duration of respirationlevels), is performed using a software program that compares thoseparameters gathered by monitoring parameters (for amplitude,periodicity, and duration of respiration during sleep) to thoseparameters (for amplitude, periodicity, and duration of respiration)gathered before the patient fell asleep. This method accuratelyidentifies the onset of a Sleep Apnea event or Hypopnea episode andeliminates false determinations. The embedded computer's softwareprogram uses rules based processing (Fuzzy Logic) to determine whenStimulation is to be applied in order to restore airway patency (byinducing inspiration). When the patient's respiration parameters aredetermined by the rules based processing (Fuzzy Logic) as showing theonset of an Sleep Apnea event or Hypopnea episode Stimulation isprovided.

The present invention may use historical data, software programs,algorithms or subroutines to assist with the determination of the rulesbased processing (Fuzzy Logic) that are appropriate to the patient. Theembedded computer's software program uses rules based processing (FuzzyLogic) to determine the least amount of Stimulation required to induceinspiration.

The Stimulation is in the form of audio signals and by a cutaneousrumble effects actuator. Rules based processing (Fuzzy Logic) determinethe least amount of Stimulation required to induce inspiration. FIGS. 1through 8, discussed below, and the various embodiments used to describethe principles of the present invention in this patent document are byway of illustration only and should not be construed in any way to limitthe scope of the invention. Those skilled in the art will understandthat the principles of the present invention may be implemented in anysuitably modified system for detecting and terminating an obstructivesleep apnea event. FIG. 1 illustrates one embodiment of the presentinvention showing External views, Top and Bottom.

The embodiment of the present invention that is illustrated in FIG. 1has Microphone 125 capable of detecting sounds within the airway ofpatient (not shown). One type of microphone that is suitable for use inthe present invention is the electret microphone. Microphone 125 isattached to the Housing 145 and Housing 145 is detachably fastenedaround the Thorax or Abdomen of the patient (not shown) with a Belt 165and Velcro clasp (not shown in FIG. 1). Housing 145 is fastened aroundthe Thorax or Abdomen of the patient (not shown) so that Microphone 125is positioned adjacent to the lungs and in contact with the patient (notshown on FIG. 1). LEDs 115 & 120 are Status indicators. The emittedcolor that the LEDs display are indicative of operational conditions ofthe present invention. Buttons 105 & 110 control the operations of thepresent invention.

The Microphone 125 is capable of generating signals representative ofthe sounds of breathing of person 120. When Microphone 125 detectssounds of breathing, it generates a signal. The signal generated by theMicrophone 125 is transferred via an individual microphone signal lineto signal processing circuitry 200 (shown in FIG. 3) contained withinHousing 145.

FIG. 2 is a cross-section (side view) of the present invention Itillustrates that belt 265 has one end attached to Housing 245. The otherend of belt 265 enters Housing 245 and is attached to Shuttle 270 andtoo Spring 290. Shuttle 270 travels within Guide 275. Shuttle 270 isattached to Wiper 280. Wiper 280 is an attachment of MembranePotentiometer 285. The expansion of the Thorax or Abdomen duringinspiration causes Belt 265 to pull on Shuttle 270 moving it from its'rest position. Shuttle 270 moves within Guide 275 and deforms Spring290. The movement of Shuttle 270 also moves Wiper 280. Wiper 280 ispressed down on the top layer of Membrane Potentiometer 285, which inturn touches the bottom layer of Membrane Potentiometer 285. Thetouching of the upper and lower layer of Membrane Potentiometer 285creates a voltage divider circuit. The output is voltage. The voltage isa direct inferential reading of the magnitude of the expansion orcontraction of the Thorax/Abdomen at any time. The Computer processesthe voltage as a Signal. The Signal output of Membrane Potentiometer 285varies in direct proportion to the position of Shuttle 270 within Guide275. When an exhalation occurs the Thorax or Abdomen contracts,releasing tension on Shuttle 270. Spring 290 moves Shuttle 270 backtowards its rest position within Guide 275. Those skilled in the artwill understand the method of using Membrane Potentiometers to senseposition. The cutaneous rumble effects actuator 200 is attached to theHousing 245. The collection of elements of FIG. 2 makeup the IntegratedPlethysmographic Sensor.

FIG. 3 is a Block Diagram of the manner in which Microphone andPlethysmographic sensor data is converted into Signals. Referring now toFIG. 3A the Block Diagram is illustrative of the Signal that isoutputted from the Integrated Plethysmographic Sensor 301. Buffer 302conditions the voltage Signal from Plethysmographic Sensor 301. Thevoltage Signal from Buffer 302 is the Thorax/Abdomen Movement Signal303. The Computer (not shown in FIG. 3) Processes the Signal 303.

Referring to FIG. 3B the Block Diagram is illustrative of the Processthat the Signals of Breathing Sounds 313 and Heart Beat Sound 312 thatare extracted. The Microphone 304 detects a multiplicity of AudioSignals. The multiplicity of Audio Signals are comprised of the Audiocomponents of biologic processes (Heart Beats, audio component of theturbulence that occurs in the human respiratory system duringrespiration, bowels, snoring, wheezing, yawning, coughing, etc) andexternal interference artifacts. The multiplicity of signals forms aspectrum of Audio frequencies. The elements of the Block Diagram asrepresented in FIG. 3B (Buffer 305, Bandpass Filter 306, EnvelopeDetection 307, Log 308, Sum 309, Integrator 310, and Output Scaling 311)act in concert to filter out the extraneous signals so as to export onlythe Signals of Respiration 313 and the Signals of the Beating Heart 312.The Process is further detailed in the technical paper ENDER, Derek etal. Process for the Detection and Analysis of Respiratory Airflow andSnoring Sounds During Sleep Using Laryngeal Sound Discrimination:Engineering in Medicine and Biology Society, 1992. Vol.14. Proceedingsof the Annual International Conference of the IEEE. Volume 6, Issue , 29Oct.-1 Nov. 1992 Page(s):2636-263. Which is hereby incorporated byreference. The Computer (not shown in FIG. 3) processes the exportedSignals. Those skilled in the art will understand this method to extractspecific Audio Signals from a multiplicity of Audio Signals.

Referring again to FIG. 3C. The Signals that are derived by thePlethysmographic Sensor 301 and the Microphone 304 are Measured by theComputer (not shown in FIG. 3). Each Signal is Measured for three (3)discrete Parameters. The Measurement quantity is assigned a numericvalue that represents a direct inferential reading of the specificSignal Parameter. The Parameters that are Measured are the: Amplitude313 of the Signal. The Amplitude 313 is representative of the expansionof the Thorax or Abdomen during an inspiration. Duration of the Signal314. The Duration of the Signal 314 is the amount time that it takes foran discrete inspiration and exhalation to be completed. Periodicity ofthe Signal 315. The Periodicity of the Signal 315 is the time betweendiscrete exhalations.

FIG. 4 is a Block diagram of the Electronic and Electrical elements ofthe invention. The operation of the invention is illustrated in FIG. 4.It is made up of a number of electronic component sections:

PIC Computer 409 is the Computer of the invention. On/Off Switch 401activates and deactivates the invention. Control1 Switch 402 activationis the method wherein that patient interacts with the invention. StatusLED2 403 is a multicolor LED. The color that it presents to the patientindicates the status of the invention. Status LED1 404 is a multicolorLED. The color that it presents to the patient indicates the status ofthe invention. Battery Pack 405 provides electrical power to theinvention.

FLASH RAM 406 contains the Force Portraits 601, the Fuzzy Control SystemRules, and the Processing program instructions. The Computer 409 and itexchange data over a signal buss. SRAM 407 contains the results ofarithmetic computations by the Computer 409. The Computer 409 and itexchange data over a signal buss. Clock Oscillator 408 is the Inventionsclock. BlueTooth 410 is the section that receives Audio PortraitSignals, Alarm Signals, and Training Period 1 & 2 spoken commands,converts the signals into Bluetooth formatted Signals and wirelesslytransmits the Audio Portrait Signals to a Bluetooth wireless Earbud 715(not shown if FIG. 4) worn by the patient. Speaker 411 Audio PortraitSignals, Alarm Signals, and Training Period 1 & 2 spoken commands andbroadcasts them to the patient. USB I/O Port 413 is the means by whichexternal devices communicate with the Computer 409. Signals 414, 415,and 416 are the busses by which the Signals are received by the Computer409 for Processing.

FIG. 5 is a Block Diagram of the Training and Monitoring Processes. Itis a primary object of the present invention to provide a apparatus andmethod for detecting and terminating an Sleep Apnea event and Hypopneaepisode, within seconds of aid detection. To perform the process I drawyour attention to FIG. 5A. FIG. 5A is a block diagram of the Process ofTraining. The Signals that are generated during Training Periods #1 and#2 are used by the invention to perform Self-checking. ThisSelf-checking procedure verifies that the invention is operating asintended.

The Process of Self-Checking commences when the patient dons theinvention and presses button On/Off Switch 401 (not shown in FIG. 5).The patient is directed to adjust the Belt 165 (not shown in FIG. 5) andVelcro clasp by plain, spoken commands. These spoken commands arefetched from FLASH RAM 406 (not shown in FIG. 5) by the Computer 409(not shown in FIG. 5) and broadcast to the patient by Bluetooth wireless410 (not shown in FIG. 5) to the patients Bluetooth Earbud 715 (notshown in FIG. 5) and/or the Speaker 411 (not shown in FIG. 5). Thedirections are supplied to the patient to insure that the IntegratedPlethysmographics' Shuttle 270 (not shown in FIG. 5) is in its' restposition within Guide 275 (not shown in FIG. 5) that allows foruninterrupted movement of the Shuttle 270 (not shown in FIG. 5) duringinspiration and exhalation. Furthermore, the Signals are Measured tobecome a set of Referential Parameters (the process that is used tocreate these Referential Parameters is addressed in detail later in thisdocument).

The Process of Training: During Training Period #1, the patent isdirected to breath in specific patterns by plain, spoken commands. Thesespoken commands are fetched from FLASH RAM 406 (not shown in FIG. 5) bythe Computer 409 (not showing FIG. 5) and broadcast to the patient byBluetooth wireless 410 (not shown in FIG. 5) to the patients BluetoothEarbud 715 (not shown in FIG. 5) and/or the Speaker 411 (not shown inFIG. 5). This Process of Training commences when the patient dons theinvention and presses button On/Off Switch 401 (not shown in FIG. 5) Thespecific patterns include but not limited to:

“Natural Breathing”

“Deep Breathing”

“Fast Breathing”

“Slow Breathing”

“No Breathing”

“Shallow Breathing”

“Breath while Supine”

“Breath on the patients Left Side”

“Breath on the patients Right Side”

“Breath while Prone”

During Training Period #2 the patent is directed to push the Control1Switch 402 (not shown in FIG. 5) as they are preparing to go to sleep.All Signals are Measured by the Computer 409 (not shown in FIG. 5) toderive Values for the Signals intrinsic Parameters. All Signals areMeasured and Processed in an identical manner.

To illustrate how Signals are Measured by the Computer 409 (not shown inFIG. 5) to derive Values for the Signals' intrinsic Parameters and thenProcessed we will use the Measurement of a single Parameter as anexample. Review FIG. 5A. For this example, the Signal Parameter thatwill be Measured and Processed is “Amplitude” 316 (not shown in FIG. 5):The “Amplitude” is representative of the expansion of the Thorax orAbdomen that occurs during an inspiration:

1. Signal Input Storage 501, collects the stream of Signals 303 (notshown in FIG. 5), 312 (not shown in FIGS. 5), and 313 (not shown in FIG.5) for 60 seconds.

2. Within Block 502 the Signals from within Signal Input Storage 501 areMeasured. Values are Processed so that only the largest Value for anyInspiration is kept.

-   -   a. The method of this specific Processing follows this format:        -   i. IF Value(Now) is GREATER than or EQUAL to Value(Previous)            THEN assign Value(Now) to Value(Previous).        -   ii. IF Value(Now) is Less than or Equal to Value(Previous)            THEN store Value(Previous) within Value Storage 503 as it is            the largest value for this Inspiration.

3. The stored largest Values within Value

Storage 503 form a set named VS.

4. The Values set VS is arithmetically Processed in the following mannerwithin Block 504—

-   -   a. Calculate the arithmetic average of the Values in the set VS.    -   b. Subtract each Value in the set from the arithmetic average.    -   c. Square the deviation of each Value in the set from the        arithmetic average.    -   d. Calculate the arithmetic average of the Squared deviations.    -   e. Calculate the square root of the arithmetic average of the        Squared deviations.    -   f. The result is the root-mean-square deviation.

5. The arithmetic average of the Values in the set VS is stored as aReferential Parameter in the Training Period 1 and 2 ReferentialParameter Storage 505.

6. The root-mean-square deviation of the Values in the set VS is storedas a Referential Parameter in the Training Period 1 and 2

Referential Parameter Storage 505.

The Process of Monitoring: It is a primary object of the presentinvention to provide an apparatus and method for detecting andterminating a Sleep Apnea event and Hypopnea episode, within seconds ofthe detection. FIG. 5B is a block diagram of the Process of Monitoring.The Signals Input Flow 506 comprises Signals 303 (not shown in FIG. 5),312 (not shown in FIGS. 5), and 313 (not shown in FIG. 5). Signals InputFlow 506 is Measured and Processed by the Computer by Value Assignment507. The Processing steps are—

1. Upon the Measurement by the Computer 409 (not shown in FIG. 5) aNumeric Value is assigned for each Parameter that is Measured.

2. The Numeric Value is stored in Numeric Value Storage 508.

3. Subtraction arithmetic operation 509. Parametric Numeric Value(Now)minus it's arithmetic average Referential Parameter equals Result1.

The Numeric value for a Parameter is further Processed by the Computer(not shown in FIG. 5) by recalling the Referential Parameters specificto the Parameter that is being Processed at this time.

The Processing consists of a series logic operation by the Computer (notshown in FIG. 5). The format of these series of logic operationPerformed within Evaluation 510:

1. If Result1 is equal or Greater than 0 then Do Nothing.

2. If Result1 is Less than 0 then

-   -   a. Subtract Parametric Numeric Value(Now) from each Value        contained within the Value Set of VS.    -   b. If any result of the previous operation (step 2a) is a        positive integer then:        -   I. Divide Result1 by the root-mean square deviation            Referential Parameters parameter equals Result2.        -   II. If Results2 is Less than 0 then Do Nothing        -   III. If Results2 is Greater than 0 then present Results2 to            the Fuzzy Control System for determination as to whether            Stimulation should be applied.

FIG. 6 is a Block Diagram of the Fuzzy Control System The Detecting andTerminating Process utilizes Fuzzy logic processes. The Fuzzy ControlSystem controls two Processes.

1. Monitoring

2. Stimulation

Fuzzy logic processing is described, for example, in U.S. Pat. No.7,426,435, issued to GAUTHIER , et al. Sep. 16, 2008, The disclosures ofthese United States patents are incorporated herein by reference.Another example is NAZERAN, HOMER et al. A Fuzzy Inference System forDetection of Obstructive Sleep Apnea: Proceedings—23rd AnnualConference—IEEE/EMBS Oct. 25-28, 2001, Istanbul, TURKEY, which is herebyincorporated by reference.

Referring to FIG. 6, the Fuzzy Control System Process for Monitoring isas follows: Result2 values are the input variables to the Fuzzy ControlSystem. The Result2 values are mapped into by sets of membershipfunctions known as “fuzzy sets”. The process of converting a Result2values (in the nomenclature of Fuzzy Logic these Result2 values arereferred to as Crisp Input Values) to a fuzzy value is called“fuzzifi-cation”. The fuzzification” occurs in the Input stage 601 ofthe Fuzzy Control System. The “fuzzified” Result2 values are evaluatedin the next stage of the Fuzzy Control System, the Processing stage 602.The Processing stage 602 uses a collection of logic rules. The Computerthen makes decisions for what action to take based on that collection oflogic rules. The Rules are in the form of IF statements:

An example of a logic rule would be:

-   -   IF amplitude IS very low AND periodicity IS very long apply        stimulation.

In this example, the two input variables are “very low” and “very long”that have values defined as fuzzy sets. The output variable,“stimulation”, is also defined by a fuzzy set that can have values like“long”, “louder, “less loud”, and so on. The results of the ProcessingStage are combined to give a specific (“Crisp”) answer; this “Crisp”answer translates results into values. This takes place in the CrispControl Stage 604. If the “Crisp” answer is to initiate Stimulation thenthe Process steps are as described or shown herein.

FIG. 7 is a diagram of a typical Patient wearing the invention. Patient700, has the positioned the Housing 705 on his Thorax and has fastenedBelt 710 to hold it in place. The patient 700 is wearing the BluetoothEarbud 715.

FIG. 8 is a Block Diagram of Portrait Development. Before continuing itmay be advantageous to set forth definitions of certain words andphrases. Stored Portrait Stimulation Parameters are

Effective Portraits

Irritation Index

Audio Portrait

Force Portrait

Effectivity Index

Effective Portraits:

Is that combination of an Audio Portrait and a Force Portrait that havebeen found through a Process (described below) to generate aninspiration in a Patient who is having an Sleep Apnea event or Hypopneaepisode.

Irritation Index:

The Irritation Index is an arbitrary value assigned to Portraits Audioand Force) at the time that the Portrait is created and inputted intothe FLASH RAM 406. It is indicative of how reactive a patient would beto that Portrait, As an example, the playing of an Audio file of a womanscreaming would be assigned a higher Irritation Index value than that ofAudio file of a birds singing.

Force Portrait:

The mechanical tactile sensory stimulator 200 (not shown in FIG. 6)differ from a simple vibrator in that it is capable of simulating a widerange of tactile effects. The Haptic effects are assembled by usingsoftware instructions to control the force amplitude, wave shape, andpulse duration to the stimulation effectors. These instructions arecombined to form Force Portraits. The Force Portraits are stored in theHaptic effects library area of the Portrait Storage 801 (not shown inFIG. 6). Different Force Portraits are felt as different tactilesensations by the patients. These Force Portraits are assigned anIrritation Index value. The choice of which Force Portrait to use forthe mechanical tactile sensory stimulator is determined by the FuzzyLogic System.

Audio Portrait

A method of Stimulation is the playing of prerecorded Audio files. TheseAudio files are stored in the Portrait Storage 801 (not shown in FIG. 6)as Audio Portraits. The Audio Portrait is made up the Audio File Name, aVolume value, the File length, and the Audio File Irritation Indexvalue. There are multiplicities of stored Audio Portrait. The Audiofiles are sent to the patient by a Bluetooth wireless transmitter 410(not shown in FIG. 6) to a Bluetooth wireless Earbud 715 (not shown inFIG. 6). Bluetooth is a wireless protocol utilizing short-rangecommunications technology facilitating data transmission over shortdistances from fixed and/or mobile device. Bluetooth wirelesscommunication is described, for example, in U.S. Pat. No. 7,225,064,issued to FUDALI, et al. May 29, 2007. The disclosures of these UnitedStates patents are incorporated herein by reference. The choice of whichAudio Portrait to use for the Audio Stimulus is determined by the FuzzyLogic System.

Effectivity Index:

The Effectivity Index is the sum of the Irritation Indexes of an Audioand Force Portraits couple. The larger the numerical value of theEffectivity Index than the more vigorous the Stimulus delivered to thepatient. The present invention relates to an apparatus to detect and endan occurrence of a Sleep Apnea event or Hypopnea episode, in a mannerthat will decrease or eliminate hypoxia, hypercapnia and the disturbanceof pulmonary hemodynamics.

To apply Stimulus in a manner that will decrease or eliminate hypoxia,hypercapnia and the disturbance of pulmonary hemodynamics it isnecessary to determine what stimuli is both effective in initiatingInspiration within 2 seconds of the stimulus application whilesimultaneously decreasing or eliminating the disturbance of pulmonaryhemodynamics.

The Method to develop a set of stimuli that is both effective ininitiating Inspiration within 2 seconds of the Stimulus applicationwhile simultaneously decreasing or eliminating the disturbance ofpulmonary hemodynamics is as follows. The sets of stimuli are calledEffective Portraits. When the Fuzzy Control System Process of FIG. 6(not shown in FIG. 8) detects the onset of a Sleep Apnea event orHypopnea episode, it attempts to select the of Effective Portrait fromwithin Portrait Storage 801.

If there is no Effective Portrait (as would happen when the patientinitially dons the invention then the Process of developing an EffectivePortrait commences:

1. The Fuzzy Control System of FIG. 6 (not shown in FIG. 8) inputs arandom selection of a Force and Audio Portrait from the Portrait Library802 forming a Temporary Couple.

2. The Temporary Couple is sent to the Stimulus Effectors 806.

3. After a 2 Second Delay 805 the Fuzzy Logic System of FIG. 6 (notshown in FIG. 8) Monitors the patient to determine if there isaninspiration.

4. If Fuzzy Logic System of FIG. 6 (not shown in FIG. 8) determines thatfurther Stimulation is required then another random selection of a Forceand Audio Portrait is made from the Portrait Library 802 forming anotherTemporary Couple.

5. This Temporary Couple will have a larger Effectivity Index than theprevious Temporary Couple Effectivity Index.

6. This Temporary Couple is sent to the Stimulus Effectors 806.

7. After a 2 Second Delay 805 the Fuzzy Logic System of FIG. 6 (notshown in FIG. 8) Monitors the patient to determine if there is aninspiration.

8. Steps 5-7 cycle until the Fuzzy Logic System of FIG. 6 (not shown inFIG. 8) determines that Stimulus is no longer required. The TemporaryCouple is stored in Portrait Storage 801 as an Effective Portrait.

Effectivity of the Effective Portrait changes in a cyclic pattern duringsleep as the amount of Stimulus required to initiate an inhalation waxesand wanes. This is the Method for adapting to that cyclic process—Whenthe Fuzzy Control System Process of FIG. 6 (not shown in FIG. 8) detectsthe onset of a Sleep Apnea event or Hypopnea episode, it attempts to usethe Effective Portrait that has been stored in Portrait Storage 801. Ifthere is an Effective Portrait in Portrait Storage 801 then the FuzzyControl System of FIG. 6 (not shown in FIG. 8) will:

1. Send that Effective Portrait to the Stimulus Effectors 806.

2. After a 2 Second Delay 805 the Fuzzy Logic System of FIG. 6 (notshown in FIG. 8) Monitors the patient. If the Fuzzy Logic System of FIG.6 (not shown in FIG. 8) determines that further Stimulation isrequired—.

-   -   a Force and Audio Portrait is chosen from the Portrait Library        802 forming a Temporary Couple whose Effectivity Index is        incrementally greater than the Effectivity Index of the        Effective Portrait stored in Portrait Storage 801.    -   b. Sends that Effective Portrait to the Stimulus Effectors 806.        -   i. Step 2 cycles until the Fuzzy Logic System of FIG. 6 (not            shown if FIG. 8) determines that there exists' no need            further for Stimulation (an inhalation is detected).        -   ii. This Temporary Couple replaces the Effective Portrait            stored within Portrait Storage 801.

3. If the Fuzzy Logic System of FIG. 6 (not shown in FIG. 8) determinesthat no further Stimulation is required then when the next Sleep Apneaevent or Hypopnea episode is detected—.

-   -   a Force and Audio Portrait is chosen from the Portrait Library        802 forming a Temporary Couple whose Effectivity Index is        incrementally less than the Effectivity Index of the Effective        Portrait stored in Portrait Storage 801.    -   b. Sends that Temporary Couple to the Stimulus Effectors 806.    -   c. After a 2 Second Delay 805 the Fuzzy Logic System of FIG. 6        (not shown in FIG. 8) Monitors the patient.        -   i. If the Fuzzy Logic System of FIG. 6 (not shown in FIG. 8)            determines that no further Stimulation is required then this            Temporary Couple replaces the Effective Portrait stored            within Portrait Storage 801.        -   ii. If the Fuzzy Logic System of FIG. 6 (not shown in            FIG. 8) determines further Stimulation is required then 1) a            Force and Audio Portrait is chosen from the Portrait Library            802 forming a Temporary Couple whose Effectivity Index is            incrementally greater than the Effectivity Index of the            Effective Portrait stored in Portrait Storage 801.

2) Sends that Effective Portrait to the Stimulus Effectors 806.

3) After a 2 Second Delay 805 the Fuzzy Logic System of FIG. 6 (notshown in FIG. 8) Monitors the patient.

4) Step 3) cycles until the Fuzzy Logic System of FIG. 6 (not shown ifFIG. 8) determines that there exists' no need further for Stimulation(an inhalation is detected.

5) This Temporary Couple replaces the Effective Portrait stored withinPortrait Storage 801.

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What is claimed is:
 1. An apparatus comprising: a Microphone disposedproximal to a patient for sensing and conveying data indicative ofrespiration and providing corresponding signals; a Plethysmograph forsensing and conveying data indicative of respiration and providingcorresponding signals; a computer configured for processing signalsgenerated by the Microphone and Plethysmograph and generating a controlsignal in response thereto; a patient stimulator, responsive to saidcomputer control signal, comprising at least one of a mechanical tactilesensory stimulator, an audio effects broadcaster, a speaker, and aBluetooth Ear-bud.
 2. The apparatus of claim 1, wherein saidPlethysmograph is a resistive Plethysmograph.
 3. A method, comprising:detecting patient respiration with a microphone and generatingcorresponding signals; detecting patient respiration with aplethysmograph and generating corresponding signals; processing saidmicrophone signals and said plethysmograph signals and includingdetecting a sleep disorder, wherein a corresponding control signal isprovided when said sleep disorder is detected; and stimulating saidpatient with at least one of a mechanical tactile stimulator, an audioeffects broadcaster, a speaker, and a Bluetooth ear bud.
 4. The methodof claim 3 wherein said wherein processing includes storing in memorysignals derived from a process of self-calibration.
 5. The method ofclaim 4 wherein said storing signals of the processes ofself-calibration is storing a collection of respirations that from a setof reference respirations.
 6. The method of claim 5 wherein said step ofprocessing included calculating the parameters of amplitude,periodicity, and wave width of respiration for each respiration of thecollection of respirations from the processes of self-calibrations. 7.The method of claim 3 wherein said processing comprises processingaccording to a computer program using rules based processing todetermine occurrences of Sleep Apnea events and Hypopnea episodes. 8.The method of claim 7 wherein said computer program uses rules basedprocessing to determine the parameters of the stimulation required toinduce inspiration to terminate at least one of a Sleep Apnea event andHypopnea episode.
 9. The method of claim 8 wherein said computer programuses rules based processing to determine the least amount of stimulationrequired to induce inspiration to terminate a Sleep Apnea event orHypopnea episode.
 10. The method of claim 9 wherein said processingincludes determining a the stimulus threshold the very first time thatthe patient uses the invention and storing the stimulus threshold valuesas that patient's stimulus baseline.
 11. The method of claim 10 whereinsaid processing includes using the stored stimulus threshold values asthe initial parametric settings for the application of stimulus at thenext and all subsequently detected Sleep Apnea events and Hypopneaepisode.
 12. The method of claim 11 wherein said processing includeapplying fuzzy logic rules to constantly adjust the stored stimulusthreshold values relative to which the initiation of an inspiration foreach specific sleep cycle is determined.
 13. The apparatus as recited inclaim 1, wherein said mechanical tactile sensory stimulator comprises acutaneous rumble effects actuator disposed to engage a peripheralsensory area on the patient, said rumble effects actuator uses aneccentric bi-directional motor to generate at least one of pulsing,spinning, multiple, superimposed vibrations, and oscillating modes tostimulate the patient to induce inspiration.
 14. The apparatus asrecited in claim 1, wherein said patient stimulator provides audioeffects, said audio effects are a generated in response to at least oneof a plurality of embedded sound files embedded in the inventions memoryto stimulate the patient to induce inspiration.
 15. The apparatus asrecited in claim 14, wherein said audio effects is broadcast to thepatient to the patient by the use of Bluetooth wireless protocol. 16.The apparatus as recited in claim 1, further including a housingreceiving at least said processor therein, and an adjustable beltreceiving said housing thereon.
 17. The apparatus as recited in claim16, wherein said processor comprises a rules based processor.
 18. Theapparatus as recited in claim 1, wherein said processor provides storedstimulus threshold data corresponding to prior control signals generatedto stimulate said patient.
 19. The apparatus as recited in claim 1,wherein said processor provides said control signal to at least one ofsaid audio effects broadcaster, said speaker and said Bluetooth ear budto be received and understood by said patient as plain, spoken languageinstructions as how to adjust the invention to provide desiredmonitoring of said patients' respirations during sleep.
 20. Theapparatus as recited in claim 19 wherein said processor includes amemory having sound files corresponding to the plain, spoken languageinstructions.